Navigation Links
Perrigo Initiates Nationwide Voluntary Product Recall Of Acetaminophen Infant Suspension Liquid, 160 mg/5 mL, Due To A Potential Defect With The Co-Packaged Oral Syringe
Date:11/1/2013

ALLEGAN, Mich., Nov. 1, 2013 /PRNewswire/ -- The Perrigo Company (NYSE: PRGO; TASE) announced today that it has initiated a voluntary, nationwide product recall to the retail level of 18 batches of its acetaminophen infant suspension liquid, 160 mg/5 mL, sold in 2 oz. and 4 oz. bottles with syringes in a box under the store brand products listed below. The recall is being initiated because of the remote potential that a small number of packages might contain an oral dosing syringe without dose markings. The correct syringe should have a white or yellow plunger with specific dose markings for 1.25 mL, 2.5 mL, 3.75 mL, and 5 mL. If the product's syringe has these dose markings, consumers can continue to use the product while following labeled use instructions.

(Photo: http://photos.prnewswire.com/prnh/20131101/DE09003)
(Logo: http://photos.prnewswire.com/prnh/20120301/DE62255LOGO)

Using an oral syringe without dose markings can result in inaccurate dosing, especially in infants who could mistakenly get too high a dose.

Commenting on this market action, Perrigo's Chairman, President and CEO Joseph C. Papa stated, "There are no issues or concerns with respect to the safety or efficacy of the product, only the potential that the oral dosing device in a relatively small number of packages could be unmarked. Out of an abundance of caution, we are taking this measure to maintain the highest possible product quality standards for our retail customers and consumers. While we cannot be certain that any of these unmarked dosing devices were released into our customers' supply chains, taking this action is the right thing to do." Perrigo has not received any reports or complaints related to this defect nor have they found any product with missing dose markings on re-examination of product on hand.

This OTC product is indicated for the relief of fever and minor aches and pains and can be used in infants, children and adults. These recalled products are sold by distributors nationwide and distributed through retail stores.

Perrigo is notifying its distributors and customers by verbal and e-mail communication today, followed by formal FedEx-delivered communication. It also is arranging for return of all recalled products. Distributors/retailers that have the acetaminophen infant suspension liquid that is being recalled should stop distribution and return product.

If the oral dosing device contained in the package has dose markings, no action is required, and the consumer can continue to use the product consistent with the label instructions. If the package contains an oral dosing device that does not have dose markings, the consumer should not use the product and should call Perrigo's Consumer Affairs Department, toll free, 1-800-719-9260. Consumers should contact their physician or healthcare provider if they have any questions, or if they or their children experience any problem that could possibly be related to this drug product.

Adverse events that may be related to the use of this product may be reported to FDA's MedWatch Adverse Event Reporting Program either online, by regular mail or by fax:

  • Online: www.fda.gov/medwatch/report.htm
  • Regular Mail: use postage-paid FDA form 3500 available at:
    www.fda.gov/MedWatch/getforms.htm.
    Mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, MD  20852-9787
  • Fax: 1-800-FDA-0178
  • This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

    Recalled lots, along with their corresponding branded labels, are listed below:LabelBatchesBABIES R US

    3KK0606CARE ONE

    3HK0564EQUALINE

    3HK0672EQUATE

    3HK0672, 3JK0433, 3JK0594, 3JK0595, 3JK0653, 3JK0673, 3KK0815,
    3KK0817HARMON FACE VALUES

    3JK0594 HEALTH MART

    3HK0671HEALTHY ACCENTS

    3HK0671, 3KK0606HEB

    3KK0606KROGER

    3GK0645, 3GK0704, 3HK0671, 3JK0433, 3JK0595, 3JK0653, 3JK0433,
    3JK0595, 3GK0645, 3GK0704, 3JK0595LEADER DRUG

    3JK0433, 3JK0594MEIJER

    3JK0594, 3JK0597PUBLIX

    3JK0595RITE AID

    3GK0704TOPCARE

    3KK0359, 3KK0494UP & UP

    3HK0672WALGREEN

    3GK0704, 3HK0564, 3HK0671, 3JK0433, 3JK0595, 3JK0610, 3KK0360 

    Mr. Papa concluded by stating, "While patient safety remains our top priority, we do not expect this issue to have a material financial impact on the company, and we are reaffirming our Fiscal 2014 full-year's earnings guidance provided October 31, 2013."

    About PerrigoFrom its beginnings as a packager of generic home remedies in 1887, Perrigo Company, based in Allegan, Michigan, has grown to become a leading global healthcare supplier. The Company develops, manufactures and distributes over-the-counter ("OTC") and generic prescription ("Rx") pharmaceuticals, nutritional products and active pharmaceutical ingredients ("API") and is the world's largest manufacturer of OTC pharmaceutical products for the store brand market. Perrigo's mission is to offer uncompromised "quality, affordable healthcare products", and it does so across a wide variety of product categories primarily in the United States, United Kingdom, Mexico, Israel and Australia, as well as certain other markets throughout the world, including Canada, China and Latin America. Visit Perrigo on the Internet (http://www.perrigo.com).

    Note: Certain statements in this press release are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and are subject to the safe harbor created thereby. These statements relate to future events or the Company's future financial performance and involve known and unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, performance or achievements of the Company or its industry to be materially different from those expressed or implied by any forward-looking statements. In some cases, forward-looking statements can be identified by terminology such as "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "potential" or other comparable terminology. The Company has based these forward-looking statements on its current expectations, assumptions, estimates and projections. While the Company believes these expectations, assumptions, estimates and projections are reasonable, such forward-looking statements are only predictions and involve known and unknown risks and uncertainties, many of which are beyond the Company's control. These and other important factors, including those discussed under "Risk Factors" in the Company's Form 10-K for the year ended June 28, 2013, as well as the Company's subsequent filings with the Securities and Exchange Commission, may cause actual results, performance or achievements to differ materially from those expressed or implied by these forward-looking statements. The forward-looking statements in this press release are made only as of the date hereof, and unless otherwise required by applicable securities laws, the Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

    Contact:
    Perrigo Consumer Affairs Department
    (800) 719-92


    '/>"/>
    SOURCE Perrigo Company
    Copyright©2012 PR Newswire.
    All rights reserved

    Related medicine technology :

    1. Perrigo Company Will Release Third Quarter Fiscal 2012 Results On May 8, 2012
    2. Perrigo Reports Record Third Quarter Revenue And Earnings And Raises Full Year EPS Guidance
    3. Perrigo Company to Present at the Bank of America Merrill Lynch 2012 Healthcare Conference
    4. Perrigo Announces FDA Final Approval and Launch of Store Brand OTC Lansoprazole 15mg Capsules
    5. Perrigo Receives FDA Approval for Butoconazole Nitrate 2% Vaginal Cream
    6. Perrigo Announces FDA Final Approval Of Tris Pharmas Dextromethorphan Polistirex Extended-Release Oral Suspension
    7. Perrigo Company To Present At The William Blair Growth Stock Conference
    8. Perrigo Receives FDA Approval And Commences Launch Of Clobetasol Propionate Shampoo, 0.05%
    9. Perrigo Company Announces Quarterly Dividend
    10. Perrigo Company To Present At The Morgan Stanley Global Healthcare Conference
    11. Perrigo Company To Acquire Assets Of Sergeants Pet Care Products, Inc., For $285 Million
    Post Your Comments:
    *Name:
    *Comment:
    *Email:
    (Date:5/23/2016)... , May 23, 2016 ... Market Size, Share, Development, Growth and Demand Forecast ... Single and Other), by Application (Drug Discovery and ... End Users (Pharmaceuticals, Life Science and Biotechnology, Academic ... P&S Market Research, the global mass spectrometry ...
    (Date:5/23/2016)... -- Gamida Cell, a leader in cellular ... orphan genetic diseases, announced today it has been awarded ... Israel Innovation Authority (formerly the Office of the Chief ... The mission of the Israel Innovation Authority is to ... and technology, while stimulating economic growth. The ...
    (Date:5/20/2016)... , May 20, 2016 The ... investors believe that the industry is not far from ... today ActiveWallSt.com featured the following four equities: Anacor Pharmaceuticals ... ATHX ), Aralez Pharmaceuticals Inc. (NASDAQ: ... INFI ). Sign up for your free trading ...
    Breaking Medicine Technology:
    (Date:5/24/2016)... ... ... In light of recent heavy flooding in Houston, Texas, Pelican Water Systems ... the Houston area. , Heavy floodwaters have led to destroyed waterways and flooded reservoirs. ... not even be aware of the contamination of their water supply and thus, may ...
    (Date:5/24/2016)... Boston, MA (PRWEB) , ... May 24, 2016 ... ... of Harvard Medical School, today announced a licensing relationship that will deliver a ... care. This relationship will put the medical knowledge and expertise of Harvard ...
    (Date:5/24/2016)... ... May 24, 2016 , ... The Dream Builders Project, ... and other necessities to Eunime Orphanage in Tijuana, Mexico on Saturday, May 21st. The ... at Peter Piper Pizza. , More than 15 volunteers traveled from Los Angeles ...
    (Date:5/24/2016)... ... May 24, 2016 , ... ... and safety labels , has been featured in the National Electrical ... The eiXtra e-newsletter provides electroindustry professionals with manufacturer, regulatory, and standardization news. The ...
    (Date:5/24/2016)... Greenwich, Connecticut (PRWEB) , ... May 24, 2016 ... ... of Lyme and tick-borne disease research and education, today announced that it has ... and CEO of the Bonnie J. Addario Lung Cancer Foundation (ALCF) in San ...
    Breaking Medicine News(10 mins):